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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cantor Fitzgerald
Cerilliant
Covington
McKinsey
Express Scripts
Teva
US Army
Cipla
Julphar

Generated: February 19, 2018

DrugPatentWatch Database Preview

GLAXOSMITHKLINE Company Profile

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Summary for GLAXOSMITHKLINE
International Patents:864
US Patents:53
Tradenames:114
Ingredients:96
NDAs:160
Drug Master File Entries: 8

Drugs and US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline AMOXIL amoxicillin FOR SUSPENSION;ORAL 050460-005 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up
Glaxosmithkline Cons NICORETTE nicotine polacrilex TROCHE/LOZENGE;ORAL 022360-001 May 18, 2009 OTC Yes No 8,940,772 ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-003 Jun 13, 2008 AB RX Yes No 8,303,986 ➤ Sign Up Y ➤ Sign Up
Glaxosmithkline TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 019434-001 Oct 31, 1985 DISCN Yes No ➤ Sign Up ➤ Sign Up
Glaxosmithkline WELLCOVORIN leucovorin calcium INJECTABLE;INJECTION 089834-001 Jan 23, 1989 DISCN No No ➤ Sign Up ➤ Sign Up
Glaxosmithkline VENTOLIN ROTACAPS albuterol sulfate CAPSULE;INHALATION 019489-001 May 4, 1988 DISCN No No ➤ Sign Up ➤ Sign Up
Glaxosmithkline COMPAZINE prochlorperazine SUPPOSITORY;RECTAL 011127-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up
Glaxosmithkline AMOXIL amoxicillin FOR SUSPENSION;ORAL 050460-001 Approved Prior to Jan 1, 1982 DISCN Yes No ➤ Sign Up ➤ Sign Up
Glaxosmithkline COMPAZINE prochlorperazine maleate CAPSULE, EXTENDED RELEASE;ORAL 021019-001 Oct 6, 1999 DISCN No No ➤ Sign Up ➤ Sign Up
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-002 Sep 19, 1997 AB RX Yes No ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 4,507,323 ➤ Sign Up
Glaxosmithkline TRITEC ranitidine bismuth citrate TABLET;ORAL 020559-001 Aug 8, 1996 5,403,830 ➤ Sign Up
Glaxosmithkline AVODART dutasteride CAPSULE;ORAL 021319-001 Nov 20, 2001 5,998,427 ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan succinate TABLET;ORAL 020132-001 Jun 1, 1995 6,368,627*PED ➤ Sign Up
Glaxosmithkline Llc FLOLAN epoprostenol sodium INJECTABLE;INJECTION 020444-002 Sep 20, 1995 4,338,325 ➤ Sign Up
Glaxosmithkline VENTOLIN albuterol sulfate TABLET;ORAL 019112-001 Jul 10, 1986 3,705,233 ➤ Sign Up
Glaxosmithkline Con TRANSDERM SCOP scopolamine FILM, EXTENDED RELEASE;TRANSDERMAL 017874-001 Approved Prior to Jan 1, 1982 4,436,741 ➤ Sign Up
Glaxosmithkline TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER cimetidine hydrochloride INJECTABLE;INJECTION 019434-001 Oct 31, 1985 4,024,271 ➤ Sign Up
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-001 Dec 30, 1985 4,435,449 ➤ Sign Up
Glaxosmithkline IMITREX sumatriptan SPRAY;NASAL 020626-003 Aug 26, 1997 5,554,639*PED ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2/12/2014
➤ Subscribe Gum 2 mg ➤ Subscribe 1/22/2013
➤ Subscribe Gum 4 mg ➤ Subscribe 1/22/2013
➤ Subscribe Capsule 0.5 mg/0.4 mg ➤ Subscribe 10/26/2010
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 9/14/2010
➤ Subscribe Capsules 60 mg ➤ Subscribe 9/8/2010
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 12/21/2009
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 10/20/2009
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 7/22/2009
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 4/3/2009
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2/5/2009
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 1/8/2009
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 1/8/2009
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 11/3/2008
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 10/31/2008
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 10/14/2008
➤ Subscribe Tablets 100 mg ➤ Subscribe 10/31/2007
➤ Subscribe Tablets 150 mg ➤ Subscribe 10/30/2007
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 10/29/2007
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 11/7/2006
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 10/11/2006
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 5/9/2006
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2/4/2005
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 12/22/2004
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 10/25/2004

Non-Orange Book US Patents for GLAXOSMITHKLINE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,853,404 Muscarinic acetylcholine receptor antagonists ➤ Sign Up
8,460,706 Hydrophilic/lipophilic polymeric matrix dosage formulation ➤ Sign Up
9,144,571 Muscarinic acetylcholine receptor antagonists ➤ Sign Up
6,750,210 Formulation containing novel anti-inflammatory androstane derivative ➤ Sign Up
6,787,532 Formulation containing anti-inflammatory androstane derivatives ➤ Sign Up
7,498,321 17.beta.-carbothioate 17.alpha.-arylcarbonyloxyloxy androstane derivative as anti-inflammatory agents ➤ Sign Up
6,858,593 Anti-inflammatory androstane derivative compositions ➤ Sign Up
7,132,532 Compounds useful in the manufacture of an anti-inflammatory androstane derivative ➤ Sign Up
8,198,483 Phenethanolamine derivatives for treatment of respiratory diseases ➤ Sign Up
7,531,528 Formulation containing anti-inflammatory androstane derivatives ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for GLAXOSMITHKLINE Drugs

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0030 France ➤ Sign Up PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
6 Finland ➤ Sign Up
00517 Netherlands ➤ Sign Up PRODUCT NAME: ACETYLSALICYLZUUR EN ESOMEPRAZOLMAGNESIUMTRIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 107516 20110912; FIRST REGISTRATION: 540235954023675402375 2011120812
C/GB98/019 United Kingdom ➤ Sign Up PRODUCT NAME: A COMBINATION COMPRISING LAMIVUDINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND ZIDOVUDINE; REGISTERED: UK EU/1/98/058/001 19980318; UK EU/1/98/058/002 19980318
C/GB98/044 United Kingdom ➤ Sign Up PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
1425001/01 Switzerland ➤ Sign Up PRODUCT NAME: VILANTEROL; REGISTRATION NO/DATE: SWISSMEDIC 62969 09.01.2014
565 Luxembourg ➤ Sign Up PRODUCT NAME: BROMURE D'UMECLIDINUM; FIRST REGISTRATION DATE: 20140428
C011/2008 Ireland ➤ Sign Up SPC011/2008: 20081105, EXPIRES: 20230110
/1999 Austria ➤ Sign Up PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907
C0042 Belgium ➤ Sign Up PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Merck
Farmers Insurance
Moodys
Deloitte
Chinese Patent Office
Accenture
McKesson
Medtronic
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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